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Blujepa approved in US for gonorrhoea indication
GSK plc announced that the US FDA has approved gepotidacin (Blujepa) as an oral treatment for uncomplicated urogenital gonorrhoea in adult and paediatric patients aged 12 and older, marking the first new class of antibiotics for gonorrhoea in over three decades. This approval, based on the EAGLE-1 trial demonstrating non-inferiority to standard care, offers a crucial oral alternative for patients with limited treatment options, addressing the significant public health threat posed by Neisseria gonorrhoeae, which had over 600,000 reported cases in the US in 2023. The drug, which inhibits bacterial DNA replication through a novel mechanism, has shown a favourable safety and tolerability profile with mild to moderate gastrointestinal events being the most common adverse reactions. Disclaimer*
About this update from Gsk Plc
[{"type":"text","content":"\n\nIssued: 11 December 2025, London UK\n \nBlujepa (gepotidacin) approved by US FDA as oral option for treatment of uncomplicated urogenital gonorrhoea (uGC) \n \n· Blujepa is the first in a new antibiotic class for the treatment of gonorrhoea approved in over three decades[i]\n· Offers a new oral option for US patients with gonorrhoea currently relying on injectable treatments\n· Neisseria gonorrhoeae is a priority pathogen for the World Health Organization with significant need for new treatments[1]\n \n \n \n\nGSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application for gepotidacin as an oral option for adult and paediatric patients from 12 years of age weighing at least 45 kg who have limited or no alternative options for the treatment of uncomplicated urogenital gonorrhoea caused by susceptible strains of Neisseria gonorrhoeae (e.g., where standard of care is contraindicated, or where patients are intolerant or unwilling to use first line treatment). This milestone follows the US FDA approval of gepotidacin earlier this year as an oral treatment for female adult and paediatric patients 12 years of age and older (weighing ≥40 kg) with uncomplicated urinary tract infection (uUTI).[2]\n \nGonorrhoea is a common, sexually transmitted infection caused by Neisseria gonorrhoeae, which has been recognised by the World Health Organization as a priority pathogen1 and an urgent public health threat by the US Centers for Disease Control and Prevention (CDC).[3] It affects both men and women and if left untreated or inadequately treated, it can lead to infertility and other sexual and reproductive health complications. In 2023, there were over 600,000 cases of gonorrhoea reported in the United States according to the CDC, making it the second most commonly reported sexually transmitted infection in the country.[4] There is currently no licensed vaccine in the US for the prevention of gonorrhoea infections and the standard treatment relies on an injectable antibiotic.[5]\n \nTony Wood, Chief Scientific Officer, GSK, said: \"We're proud to have delivered the first new class of antibiotics for gonorrhoea in over three decades and a new oral option for US patients. The ability...